CHMP recommends Adempas for PAH and CTEPH-Bayer HealthCare

The European Committee for Medicinal Products for Human Use (CHMP) on 24 January 2014 recommended approval for Adempas (riociguat) tablets for use in two forms of pulmonary hypertension, a group of life-threatening and progressive diseases: The treatment of adult patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or persistent or recurrent CTEPH after surgical treatment to improve exercise capacity, and the treatment of adult patients with pulmonary arterial hypertension (PAH) to improve exercise capacity. Riociguat is the first of a novel class of drugs, the soluble guanylate cyclase (sGC)-stimulators.

Its new mode of action has been developed to target a key molecular mechanism underlying pulmonary hypertension. The final decision of the European Commission is expected in mid 2014.